Ultradent recalls Peak Universal Bond Self-Etch Bottle Kit and Intro Kit due to potential missing resin in primer, which may weaken dental bond strength. Affected kits have specific lot numbers.
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Ultradent is recalling two dental bonding kits because the primer may be missing some or all of the resin needed for proper bonding. This could lead to weaker dental restorations if used.
The primer in these kits may not contain the full resin chemistry required for bonding. Without sufficient resin, the bond strength between the dental material and tooth may be compromised, potentially leading to restoration failure.
Dentists and dental professionals who use the recalled kits for light-curing dental bonding procedures. Those most at risk are users who have the specific lot numbers listed in the recall.
Check the product label for the part numbers: 4541, 4554, or 5135. The recall includes specific lot numbers listed in the description, such as 00883205104274 for kit 4541.
Look for the part numbers 4541, 4554, or 5135 on the kit to determine if it is affected.
The primer may be missing some or all of the resin portion of the chemistry, which can impact bond strength and restoration quality.
Peak Universal Bond Self-Etch Bottle Kit (Part 4541), Peak Universal Bond Self-Etch Intro Kit (Part 4554), and Peak SE Primer 4pk Refill (Part 5135).
Check the product label for the part numbers and associated lot numbers listed in the recall description.
We’ve drafted a message you can send Ultradent to request your refund or repair — edit it as you like.
Subject: Recall Z-1368-2022 — Ultradent Ultradent Hello, I own a Ultradent that is covered by recall Z-1368-2022 from Ultradent. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.